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NASHVILLE - Insight Molecular Diagnostics (NASDAQ:IMDX), a molecular diagnostics company with a market capitalization of $106.1 million, announced Monday that its flagship transplant rejection test kit demonstrated equivalent performance to a commercially available alternative in measuring donor-derived cell-free DNA (dd-cfDNA), according to a study conducted by University Hospital Heidelberg in Germany. InvestingPro data shows the company maintains a healthy balance sheet with more cash than debt, supporting its research initiatives.
The head-to-head comparison evaluated 96 kidney transplant recipients and found that iMDx’s digital PCR-based test produced results consistent with next-generation sequencing (NGS) kits across all biopsy-proven pathology categories.
"Digital PCR showed improved analytical sensitivity, suggesting potential advantages in detecting dd-cfDNA in low quantities," said Dr. Ekkehard Schuetz, iMDx Chief Science Officer, in the press release.
The company’s GraftAssureIQ test uses digital polymerase chain reaction technology to quantify dd-cfDNA, a biomarker used to assess transplant rejection risk. The test is currently available for research purposes only and cannot be used for clinical treatment decisions.
iMDx is developing GraftAssureDx, a clinical version of the test for which it plans to seek regulatory authorization. The company aims to capture a share of what it estimates is a $1 billion transplant rejection testing market. While InvestingPro analysis indicates the company isn’t currently profitable, with a -$21.58 million EBITDA, its strong current ratio of 3.75 and impressive revenue growth of 178% over the last twelve months suggest potential for market penetration. Discover 10 more key insights about IMDX with an InvestingPro subscription.
Extended data from the study will be presented at the European Society of Organ Transplantation Congress in London, running from June 29 through July 2. The company will also exhibit at the conference at booth D46.
iMDx, which recently relocated its headquarters from Irvine, California to Nashville, Tennessee, plans to host a webinar featuring Dr. Anthony J. Langone of Vanderbilt University Medical Center, the principal investigator for the company’s ongoing kidney transplant monitoring trial. The company’s stock has shown remarkable momentum, gaining over 55% in the past week alone. Get the complete financial picture with an in-depth Pro Research Report, available exclusively on InvestingPro.
The information in this article is based on a company press release.
In other recent news, OncoCyte Corp reported its first-quarter 2025 earnings, with revenue from pharma services reaching $2.1 million, surpassing expectations due to a significant late-quarter order. The company maintains a strong cash position of nearly $33 million, bolstered by a successful fundraising effort earlier in the year. OncoCyte is actively managing its quarterly cash burn, which is anticipated to remain around $6 million throughout 2025. Needham has reaffirmed its Buy rating on OncoCyte, maintaining a price target of $4.25, reflecting confidence in the company’s strategic direction and growth potential. The company is advancing with the introduction of its GraftAssureIQ, co-marketed with Bio-Rad, and is preparing for FDA submission by the end of 2024, with approval expected in early 2026. OncoCyte is also in the process of a Phase 3 validation trial involving approximately 150 patients and aims to collaborate with 20 transplant centers in the U.S. and Germany by the end of 2025. The company’s strategic pivot towards transplant rejection testing and oncology diagnostics continues, with plans to unveil a new corporate name to better reflect its direction.
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